Stakeholder Perspectives: Mild Cognitive Impairment and Dementia

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1 A Datamonitor In-Depth Analysis Stakeholder Perspectives: Mild Cognitive Impairment and Dementia Aricept in Race to Pioneer Unexplored Markets Published: Aug-03 Product Code: DMHC1924 Why buy this analysis? Identify hot areas of the dementia and MCI market that are not being targeted by competitors Improve knowledge of important issues, such as neuroprotection, as identified by respected experts in these fields Increase future revenue potential of an MCI product by understanding what is needed to improve low diagnosis rates Understand the implications of the recent FDA non-approval of Aricept for VaD to Pfizer/Eisai and other market contenders Optimize product positioning strategies by understanding the impact and potential of memantine in the severe AD market

2 Stakeholder Perspectives: Mild Cognitive Impairment and Dementia - Aricept in Race to Pioneer Unexplored Markets DMHC1924 Introduction While the mild to moderate Alzheimer's disease (AD) market grew strongly over 2002 to exceed $1.5 billion, investors are now recognizing opportunities in other areas of the dementia population. Of particular interest is the treatment of mild cognitive impairment (MCI), which, although not a dementia as such, is considered to be a precursor to AD. At the other end of the spectrum, there is interest in the treatment of severe AD for which Lundbeck/Merz's memantine recently gained European approval. One other dementia that warrants analysis is vascular dementia (VaD), and a number of players in the AD market are currently competing to enter this potentially lucrative market. Scope and coverage Disease and diagnosis overview Epidemiology: including prevalence split by the seven major markets, diagnosis rates, and treatment rates Analysis of unmet needs as identified by opinion leaders Discussion of current drug treatment Analysis of drugs in late stage development for these areas, including Pfizer/Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine), Janssen/Shire's Reminyl (galantamine), and Lundbeck/Forest's Ebixa (memantine) Finally, a Commercial Perspectives section highlights areas of interest for future investigation and provides recommendations based on opinion leader insight Research methodology The report is based on sources including IDdb3 database, major conferences such as the American Academy of Neurology Annual Meeting, peer-reviewed journals (including Journal of Neurological Science, Neurology, American Journal of Psychiatry and many more). In addition, in-depth interviews were carried out with key opinion leaders in the therapeutic areas of mild cognitive impairment, vascular dementia and severe AD. For more information... Contact Susanne Begley, CNS Business Unit Director tel: fax:

3 Key findings and highlights There are no approved drugs for MCI and VaD, with only memantine approved for severe AD in the EU. Companies currently manufacturing AD products, Aricept, Exelon and Reminyl are expected to file NDAs for treatment of MCI during Despite Aricept's failure to gain FDA approval for VaD in July 2003, Datamonitor predicts it will be approved during 2005 and will experience the benefits of first to market status. Memantine is currently the only treatment approved for severe AD in the EU, and is expected to be launched in the US during Datamonitor predicts strong uptake in this niche market will see sales nearing blockbuster figures over the next 8 years. Unmet needs of MCI, VaD and Severe AD Delay of progression to/of AD Approval of disease modifying drugs HIGH Approval of symptomatic drugs Improved early diagnosis Non-drug treatments Increased awareness Level of unmet need Drugs with fewer side effects LOW Source: Datamonitor DATAMONITOR Report structure Disease and diagnosis overview: Discussion of the symptomology and predictive factors of the disease Epidemiology: Including prevalence split by the seven major markets, diagnosis rates, and treatment rates Unmet needs: Analysis of unmet needs as identified by opinion leaders Pharmacotherapy: Discussion of current drug treatment Key late stage clinical trial analysis: Analysis of drugs in late stage development for these areas, including Pfizer/Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine), Janssen/Shire's Reminyl (galantamine, and Lundbeck/Forest's Ebixa (memantine)...many of the diagnostic tools originally designed for AD are insufficiently accurate to diagnose MCI... Key Opinion Leader

4 Stakeholder Perspectives: Mild Cognitive Impairment and Dementia - Aricept in Race to Pioneer Unexplored Markets DMHC1924 Summary of contents DRIVERS AND TRENDS While the mild to moderate Alzheimer's disease (AD) market grew strongly over 2002 to exceed $1.5 billion, investors are now recognizing opportunities in other areas of the dementia population. Of particular interest is the treatment of mild cognitive impairment (MCI), which, although not a dementia as such, is considered to be a precursor to AD. At the other end of the spectrum, there is interest in the treatment of severe AD for which Lundbeck/Merz's memantine recently gained European approval. One other dementia that warrants analysis is vascular dementia (VaD), and a number of players in the AD market are currently competing to enter this potentially lucrative market. INTRODUCTION Insight into the symptomology and predictive factors of the disease areas with implications for improved diagnostic techniques and future prophylactic and therapeutic potential. PATIENT POTENTIAL Detailed coverage of the patient potential of the MCI, VaD and severe AD therapy areas across the seven major markets, including disease prevalence and diagnosis rates. Also, in order to optimize R&D strategy, there is comprehensive analysis of the main clinical unmet needs, as defined by interviewed opinion leaders, in each of the therapy areas. PHARMACOTHERAPY Current treatment options, including off-label usage. Treatment of comorbidities, preventative and supportive treatments are also discussed. KEY TRIAL ANALYSIS Who are the major players in the three therapy pipelines, and at what stage of clinical development are their drugs? These sections provide an overview of drugs in Phase II and III and above clinical trials. Key trials are analyzed; each drug is profiled in depth, with discussion of the strengths, weaknesses, threats and opportunities of the clinical aspects of the drug. Alternative indications are discussed and the potential strength of the drug within the market is assessed, and recommendations of key R&D strategies are given. COMMERCIAL PERSPECTIVES What areas of disease treatment and management can manufacturers address to enhance uptake of their products into the various therapy markets? Key opportunities are addressed including improved diagnostic techniques, clinical trial design, product reformulation, prophylactic potentials, off-label drug use, drug approval and reimbursement. LIST OF TABLES Table 1: Prevalence of MCI, VaD and severe AD in the seven major markets, 2003 Table 2: Diagnostic criteria for MCI Table 3: Prevalence of MCI in the seven major markets, 2003 Table 4: MCI drugs in Phase III clinical trials Table 5: VaD risk factors Table 6: The prevalence of VaD in the seven major markets, 2003 Table 7: VaD therapeutics in Phase III clinical trials Table 8: Prevalence of severe AD in the seven major markets, 2003 Table 9: Severe AD therapeutics in Phase III clinical trials LIST OF FIGURES Figure 1: Memory function and general cognition in MCI, AD and normal subjects Figure 2: Unmet needs in the treatment of MCI, 2003 Figure 3: Key factors in the market potential of Aricept Figure 4: Key factors in the market potential of Exelon...Delaying the progression to AD is the ultimate goal of treatment management of MCI, and has a number of beneficial effects for patients and healthcare systems alike... Alistair Sinclair, Neurology analyst

5 Figure 5: Key factors in the market potential of Reminyl Figure 6: Key factors in the market potential of Ampalex Figure 7: Unmet needs in the treatment of VaD, 2003 Figure 8: Drugs used to treat comorbidities of VaD Figure 9: Key factors in the market potential of Aricept Figure 10: Key factors in the market potential of Reminyl Figure 11: Key factors in the market potential of Exelon Figure 12: Key factors in the market potential of memantine Figure 13: Unmet needs in the treatment of severe AD, 2003 Figure 14: Key factors in the market potential of memantine Figure 15: Market events affecting baseline product forecasts Figure 16: Algorithm depicting key constituent variables upon which drug revenues depend Figure 17: Overview of Datamonitor Healthcare's forecasting approach for pipeline drugs Figure 18: Datamonitor's Healthcare Consultancy Figure 19: Therapeutic Consulting capabilities Keep in touch with breaking news in your industry... Datamonitor s Healthcare Digests keep you fully up to speed with the latest breaking news in the healthcare industry. Delivered to your desktop via once a week. Healthcare Digests offer a vital source of detailed insight and commentary from our expert analysts. To sign up for a Healthcare Digest, visit the registration Page: You can subscribe to up to three Healthcare Digests which focus on specialized topics: R&D Biotechnology Pharmaceuticals Key Opinion Leader...A possible reason Aricept failed to gain FDA approval for VaD is that the underlying rationale for its use in VaD is less beneficial than in AD, as VaD is an ultimately preventable disease...

6 Stakeholder Perspectives: Mild Cognitive Impairment and Dementia - Aricept in Race to Pioneer Unexplored Markets DMHC1924 Datamonitor: Your total information solution Datamonitor is a premium business information company helping 5,000 of the world's leading companies across the Automotive, Consumer Markets, Energy, Financial Services, Healthcare & Technology sectors. Our products and services are specifically designed to support our clients key business processes - from corporate strategy to competitive intelligence. We provide an independent and trustworthy source of data, analysis and forecasts to improve these processes and ultimately, to help grow your business. Corporate Strategy & Business Planning Product Development & Commercialization Targeting & Influencing the Market Market & Competitive Intelligence Quality Data Expert Analysis Future Forecasts Make more effective strategic and business decisions Accelerate delivery of commercial success Assess and influence your commercial and market environment Maintain or obtain critical competitive advantage HELPING TO GROW YOUR BUSINESS Nobody speaks louder than our clients 3M Bristol-Myers Squibb Gist Brocades Ranbaxy Abbott British Biotech GlaxoSmithKline Recordati Accenture Byk Gulden IBM Roche Ajinomoto Cantab Immuno AG Sankyo Alcon Labs Caremark International Johnson & Johnson Sanofi-Synthélabo Allergan Chiesi Jouveinal Schering AG Almirall Chiron LEK Schering-Plough Alpha-Beta Technologies Chugai Lipha Schwarz Amgen CMC Co Lundbeck Serono Amrad Daiichi Merck KGaA Shire Pharmaceuticals Angelini Acraf Dainippon Merck & Co Solvay Asta Medica Deutsche Morgan Novartis Takeda AstraZeneca AT Kearney Grenfell Eisai Novo Nordisk Nycomed Amersham Tanabe TAP Pharmaceutical Products Inc Aventis Elan Otsuka Teva Baxter Eli Lilly Pfizer UCB Bayer Esteve Pharmachemie Uriach Beaufour Ipsen Flamel Pharmacia Wyeth Biochemie Fournier Pierre Fabre Boehringer Ingelheim Fujisawa Pliva Boots Gehe Procter & Gamble 89% of our clients use Datamonitor research to develop competitive intelligence Datamonitor Customer Research

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